Minocycline Augmentation of Clozapine for Treatment Resistant Schizophrenia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Schizoaffective Disorder
- Schizophrenia
- Schizophreniform Disorder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The primary objective is to determine if the addition of minocycline to Clozapine, Treatment as Usual (TAU) Improves negative symptoms and/or positive symptoms. The secondary objectives are to determine: Effects on cognitive functioning. Effects on social functioning and quality of life. Safety and ...
The primary objective is to determine if the addition of minocycline to Clozapine, Treatment as Usual (TAU) Improves negative symptoms and/or positive symptoms. The secondary objectives are to determine: Effects on cognitive functioning. Effects on social functioning and quality of life. Safety and tolerability. Possible additive effects of Minocycline added to TAU The effect on inflammatory biomarkers associated with schizophrenia. Both pro and anti-inflammatory cytokines will be drawn at baseline and endpoint. We will test to see if minocycline is associated with improvements in abnormal cytokines as compared to placebo. The study will be a randomized double-blind placebo controlled trial of minocycline added to clozapine (Treatment as Usual) in TRS. There will be two treatment arms: one arm receiving TAU with minocycline and the other TAU with placebo for a period of twelve weeks.
Tracking Information
- NCT #
- NCT02533232
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dr.Inti Qurashi, MD Manchester University ,UK
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